Currently, there is a big debate whether or not patients with terminal illnesses should or should not have access to experimental drugs. However, there are several possible considerations to keep in mind before allowing people access unproven drugs.

One of the problems with allowing such wide access to not yet approved experimental drugs is that it makes the process of clinical trials much more difficult. Currently, drugs must undergo three phases of clinical testing to address safety & efficacy. According to Dr. Susan Okie, making it a “right” for people to have access to experimental drugs, would “fundamentally challenge the government’s system for evaluating drugs.” Furthermore, why bother participating in the clinical trial, when you can get the treatment directly?

In addition, according to the Society for Clinical Trials, legislation to open access to experimental drugs would severely “undermine the system of scientifically valid testing of new drugs that has been a bulwark of health care for several decades.”

5 comments

1. Sue Guinn, RN on October 29, 2009

   As often is the case with the government it looks at only one side. Experimental drugs would still have plenty of people willing to do the trials because or the cost of the drugs. Not only would it be fair to the consumer, it would let them see how it would effect individuals who had a wider range of diseases. People who might not qualify for a study because of pre-existing conditions would give them data about how it effects people with these conditions with out the risk and cost of covering any unexpected side-effects.
   It would go back to letting your doctor make medical judgments as to whether this is the right drug for his patient.

    
2. Jared on October 29, 2009

   I definitely see a need to ensure the safety and efficacy of prescription drugs/treatments and to be fully aware of their possible side effects before allowing widespread use. But I'm unsure how allowing a terminally ill patient access (when all approved treatments have been exhausted) to something still in the experimental phase would actually undermine the trial process. It seems to me that if a patient doesn't have the time left to risk receiving a placebo in a clinical trial or is otherwise inelligible for the trial, they ought to have access to the treatment.
   
   Perhaps I'm being too cynical, but I'd be more concerned with drug companies taking advantage of people in desperate situations...I don't know how the system really works, but I'm envisioning a drug maker pointing to positive results from patients who were allowed to bypass the trial phase in order to press for rapid FDA approval before the full effects of the treatment are known. I'd be interested to know who is lobbying for and against this legislation.

    
3. Sue Guinn, RN on October 29, 2009

   You make a very good point and I would like to take it a step further...I think it is silly to sue the drug company for not releasing the drugs. It is because of the ability of the American public to sue so freely that make it hard for drugs to be released. Tort reform would be a good first step.
   Whenever there seems to be a problem getting things done in any government agency I say "follow the money"
   If a patient goes on the drug with FULL disclosure then again I think it should be up to the patient and his doctor.
   Jared, I also am cynical and perhaps that is why the guidelines are so rigid. I think drug companies will always look at the bottom line even to the degree of placing some of the public at risk.

    
4. Angry Old White Guy on October 29, 2009

   Are all of you people nuts?
   Don’t you realize it is all about maintaining the status quo? Which is to say preserving the profitability of big drug companies? As is usually the case the government idea starts off with good motives but money is what makes government move and people in government don’t mind the grease!
   We get so focused on free enterprise that the health of the general public is put at risk because of the profit motive. I am not for nationalization of medicine, but it is unfortunate that there is not more government sponsored research at the university level without regard to the profit. Currently universities must go after grants from the drug companies to fund research and the drug companies won’t fund it if they can’t see a profit in it.
   Do you really believe that government is concerned about the impact a single drug might have on the health of a few terminally ill patients? If so, why can any adult in this country purchase a substance to smoke, chew or dip that is known to eventually kill you. Why can any idiot who has managed to live to the age of 21 walk in to any number of legal taxpaying businesses and buy a bottle of 100% pure alcohol that will “cure” any disease if you hold your breath and swallow it all? You want to know why? Free will? Freedom of choice? No, it is dollars. The government needs the taxes from this stuff. And the government system wants money from the drug companies to bring a drug to market. The difference is I’m not sure it is always the government getting the money but could be the government employees. Notice how regulators move freely between private enterprise and government office?

    
5. Casita Pena on October 29, 2009

   Hmmm, I was going to give my two cents worth to the actual blog so I will...but the angry white guy has some tremendous points!
   
   On one hand, terminally ill patients should be able to subject themselves to whatever treatments they want to - I mean, we all know how it's going to end but on the other hand, their participation in the studies would not contribute to the long-term effects of the drugs! If you're 95, perhaps long-term results are less of a concern.
   
   Just keep in mind that LIFE is terminal - what you do with it is between you and God - long as you pay your taxes the government can just stay out of it!